OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
ClinicalTrials.gov ID
NCT02145676
Lead Sponsor
AllerganINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 3
Enrollment
53Actual
Last Update Posted
Apr 12, 2017Actual
Start Date
May 2014
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
Brief Summary
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Muscle Spasticity
Stroke
onabotulinumtoxinA
placebo (normal saline)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
Exclusion Criteria:
Spasticity in the non-study upper limb that requires treatment
Presence of fixed contractures in of the study muscles in elbow or shoulder
Profound atrophy of muscles to be injected
Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
Condition other than stroke contributing to upper limb spasticity
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis